Numinus Wellness Inc. (TSX: NUMI) is pleased to announce that Cedar Clinical Research (CCR) has begun studying COMP360 psilocybin therapy, an investigational new therapy for treatment-resistant depression (TRD), as part of the largest-ever international clinical study of psilocybin therapy. Dr. Paul Thielking, Chief Science Officer at Numinus, and the team have begun accepting people with TRD who fulfill certain eligibility criteria to join the study.
The study in Draper, Utah, is a part of COMPASS Pathway’s phase 3 program in TRD. The international program is composed of two pivotal trials, each with a long-term follow-up component. It will enroll over 800 participants, with topline data expected in summer 2024 and mid-2025.
The launch of the phase 3 program follows positive results from COMPASS Pathways’ phase 2b trial, published in the New England Journal of Medicine, the world’s leading peer-reviewed medical journal. The objective of the randomized, controlled, double-blind phase 2b study was to understand the efficacy and safety of a single dose of investigational COMP360 psilocybin (25mg or 10mg), compared to 1mg, in patients with TRD. After a single 25mg dose of COMP360 psilocybin, in combination with psychological support, 29.1% of participants with TRD were in remission by week 3.
“COMPASS is helping to lead the way in psilocybin research and development for treatment-resistant depression,” said Dr. Paul Thielking, Chief Science Officer at Numinus. “We are very proud of the work we are doing alongside COMPASS to elevate the industry and contribute to the growing body of research.”
“Tens of millions of people around the world suffer with depression that doesn’t respond to traditional treatments. The results from our phase 2b study of investigational COMP360 psilocybin therapy were very encouraging, and we hope that the data from our pivotal phase 3 program will form the basis for our submission to regulatory bodies. We’re grateful to all the people involved in our phase 3 program around the world. It is a significant milestone in our journey to make COMP360 psilocybin therapy available to patients, and towards building a better future for mental health care.”
Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways
About Numinus
Numinus Wellness Inc. helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.
Cedar Clinical Research (CCR) is a wholly-owned subsidiary of Numinus Wellness Inc.